Dissolution: A Quality Control Test vs. A Bioequivalence Test

Abstract

in co m b i n ation with dissolution dat a , p rovides a rationale for biowa i ver of immediate release ( I R ) d rug prod u ct s.In addition,the Ge n e ral Bi o ava i la b i l i ty and Bi oe q u i va l e n ce guidance (4) allows b i owa i vers for lower strength(s) of immediate release as well as modified release drug prod u ct s based on fo rm u l ation pro po rt i o n a l i ty and dissolution profile co m p a ri s o n .These changes in bioe q u i va l e n ce re q u i re m e nt s, m oving away from in vivo biostudy re q u i re m e nts in ce rtain cases and relying more on dissolution te s t, c l e a rly establish a change in dissolution test applicat i o n s.In all cases where dissolution test is used as a BE te s t,an anchor with a bioavailable prod u ct is e s t a b l i s h e d.With the evolution and adva n ces in dissolution te c h n o l ogy and the understanding of s c i e ntific principles and mechanism of dissolution test re s u l t s,a clear trend has emerged where dissolution test has moved from traditional quality co nt rol test to a surrog ate in vitro bioe q u i va l e n ce te s t .This re p re s e nts a shift in dissolution thought p rocess and a new re g u l ato ry pe r s pe ct i ve on dissol u t i o n .The dissolution test has moved away fro m t raditional Q C test to a surrog ate in vitro B E te s t (Table 1).In seve ral instance s,a biowa i ver is indicated based on dissolution profile co m p a ri s o n .